RS232 Flow Sensor and Software Package
FDA 510(k) K894680 · Tamarac Systems Corp.
510(k) numberK894680
Submission
- Device name
- RS232 Flow Sensor and Software Package
- Applicant
- Tamarac Systems Corp.
Denver, CO, US - Received
- July 25, 1989
- Decision date
- October 23, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BZG – Spirometer, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1840
- Specialty
- Anesthesiology
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Questions and answers
When was RS232 Flow Sensor and Software Package cleared by the FDA?
RS232 Flow Sensor and Software Package (K894680) received a 510(k) decision of Substantially Equivalent on October 23, 1989, 90 days after the submission was received.
What is the product code of K894680?
The FDA product code is BZG – Spirometer, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 868.1840.